A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

NCT00959049 Phase 3 COMPLETED Results posted

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Details

Lead sponsor	Seqirus
Phase	Phase 3
Status	COMPLETED
Enrolment	1474
Start date	2009-09
Completion	2010-05

Conditions

• Influenza

Interventions

• CSL's Influenza Virus Vaccine (Afluria)
• Influenza Virus Vaccine (Fluzone)

Primary outcomes

• Geometric Mean Titer 30 Days After the Last Study Vaccination — 30 days after the last study vaccination
• Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination — 30 days after the last study vaccination
  Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

Countries

United States